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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER

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NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER Back to Search Results
Model Number MAXA
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problems Respiratory Distress (2045); No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, while using the device on the patient, spo2 (peripheral capillary oxygen saturation) was alarming, the pulse oximetry was in the 70¿s in parenthesis and good weight form.The patient was in bed for 5 days with spo2 form ranging 90% to 100%.A new sensor was placed on the patient and prior one had fallen off at 1400 degrees.The monitor alarmed with good weight form and patient was on respiratory distress and new sensor read 100% with same weight form with faulty one.There was patient injury reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, while using the device on the patient sp02 was alarming, the pulse oximetry was in the 70's in parenthesis and good weight form.The patient was in bed for 5 days with spo2 form ranging 90% to100%.A new spo2 sensor was placed on the patient and prior one, it had fallen off at 1400 degrees.The monitored alarmed with good weight form and patient was on respiratory distress and new sensor read 100% with same weight form with faulty one.There was no patient injury.
 
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Brand Name
NELLCOR
Type of Device
OXIMETER
Manufacturer (Section D)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX  22225
Manufacturer (Section G)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX   22225
Manufacturer Contact
avi kluger
15 hampshire street
mansfield, MA 02048
3035306582
MDR Report Key7542302
MDR Text Key109186158
Report Number1282497-2018-00412
Device Sequence Number1
Product Code DQA
UDI-Device Identifier20884522040089
UDI-Public20884522040089
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012891
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Model NumberMAXA
Device Catalogue NumberMAXA
Device Lot Number180470269H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/19/2018
Initial Date FDA Received05/24/2018
Supplement Dates Manufacturer Received08/21/2018
Supplement Dates FDA Received08/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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